Lung Cancer, Nonsmall Cell Clinical Trial
Official title:
Phase II Study of Induction Platinum Doublet in Combination With Nivolumab Followed by Surgery or Concurrent Chemoradiation in Unresectable Stage IIIA-C Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
Status | Recruiting |
Enrollment | 37 |
Est. completion date | August 2027 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated - PD-L1 level needs to be measured with values 0-100% eligible - EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes - ECOG Performance Status = 1 - Adequate organ and marrow function - Adequate pulmonary reserve (e.g., FVC, FEV1, TLC, FRC, and DLCO) capable of tolerating the proposed lung resection - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen - Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification class 2B or better - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment - Any prior radiotherapy to the lung - Any prior treatment for NSCLC - Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways - Any history of a severe hypersensitivity reaction to any monoclonal antibody - Any history of allergy to the study drug components - primary tumors involving the esophagus - pancoast tumors - Patients cannot have primary tumors which would remain unresectable - History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in study - Any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications - Ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg - previous malignancies - history of interstitial lung disease - Patients requiring continuous supplemental oxygen - Use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy - Active systemic infection requiring therapy - Patients with uncontrolled intercurrent illness - Patients with psychiatric illness/social situations that would limit compliance with study requirements - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Ralph G Zinner | Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate after induction | post induction radiographic response by cat scan | 9 weeks | |
Secondary | Change in Toxicity | To assess safety, investigators will evaluate the rate of toxicity as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system. | through study completion, up to 18 months | |
Secondary | Percent of participants receiving surgery | Rate of converting non-surgical stage III(A-C) to surgically resectable disease | date of surgery, approximately 10 weeks | |
Secondary | Pathologic complete response (pCR) | Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen | post surgery, approximately 10 weeks | |
Secondary | Major pathological response (MPR) | MPR rate, defined as number of participants with = 10% residual tumor in lung and lymph nodes | post surgery, approximately 10 weeks | |
Secondary | Progression free survival (PFS) | PFS is defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first. | 2 years | |
Secondary | overall survival (OS) | defined as the duration of time from start of treatment to time of death | 2 years | |
Secondary | Change in patient-reported Quality of Life as measured by FACT-TOI | patient-reported Quality of Life as measured by FACT-TOI (Functional Assessment of Cancer Therapy - Trial Outcome Index); defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS (lung cancer scale) scores obtained from 7-item questionnaires from the FACT-L (Version 4.0). Questions are on a 5-point scale from 0-4, where 0 = "not at all" and 4 = "very much." Scores range from 0 to 84; higher score indicates better physical aspects of quality of life (QoL). | through study completion, up to 18 months |
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